Diabetes Autoimmunity Withdrawn In New Onset and In Established Patients
Public ClinicalTrials.gov record NCT03895437. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of TOL-3021 in Patients With New Onset or Established Type 1 Diabetes Mellitus
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study is a prospective, randomized, 52-week double-blind, placebo-controlled, multicenter trial in subjects with Type 1 diabetes (T1D) followed by a 2-year safety follow-up.
Study identification
- NCT ID
- NCT03895437
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 78 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years to 40 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 17, 2019 (Actual)
- Primary completion
- Dec 21, 2020 (Actual)
- Completion
- Dec 21, 2020 (Actual)
- Last update posted
- May 20, 2026
2019 – 2020
United States locations
- U.S. sites
- 23
- U.S. states
- 14
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Altman Clinical and Translational Research Institute UCSD | San Diego | California | 92093 | — |
| University of California San Francisco | San Francisco | California | 94143 | — |
| Mills-Peninsula Medical Center | San Mateo | California | 94401 | — |
| Stanford University | Stanford | California | 94305 | — |
| Barbara Davis Center - University of Colorado Denver | Denver | Colorado | 80045 | — |
| Yale University | New Haven | Connecticut | 06520 | — |
| University of Florida | Gainesville | Florida | 32610 | — |
| Baptist Health Research Institute | Jacksonville | Florida | 32258 | — |
| University of Miami Diabetes Research Institute | Miami | Florida | 33136 | — |
| University of South Florida Diabetes Center | Tampa | Florida | 33612 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| Rocky Mountain Clinical Research | Idaho Falls | Idaho | 83404 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| MedStar Health Research Institute | Baltimore | Maryland | 21239 | — |
| MedStar Health Research Institute | Hyattsville | Maryland | 20782 | — |
| Joslin Diabetes Center- Adult & Pediatric | Boston | Massachusetts | 02215 | — |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | — |
| Naomi Berrie Diabetes Center, Columbia University | New York | New York | 10032 | — |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | — |
| Mountain Diabetes and Endocrine Center | Asheville | North Carolina | 28803 | — |
| University of North Carolina Diabetes Care Center | Chapel Hill | North Carolina | 27517 | — |
| Diabetes and Glandular Disease Clinic, P.A. | San Antonio | Texas | 78229 | — |
| University of Virginia | Charlottesville | Virginia | 22903 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03895437, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 20, 2026 · Synced Nov 3, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03895437 live on ClinicalTrials.gov.